US2022039833A1PendingUtilityA1

Anchor for transcatheter access into the coronary sinus

Assignee: EDWARDS LIFESCIENCES CORPPriority: Apr 22, 2019Filed: Oct 21, 2021Published: Feb 10, 2022
Est. expiryApr 22, 2039(~12.7 yrs left)· nominal 20-yr term from priority
A61M 25/10A61B 2017/00292A61B 17/3423A61M 25/1002A61M 25/04A61F 2/2451A61M 25/0133A61F 2/2466A61M 2025/1086A61B 2017/00243A61B 2017/3486A61B 2017/3425A61M 2025/1061A61B 17/3468A61M 25/0662
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Claims

Abstract

A delivery sheath can comprise an elongate tubular member and an anchor on a distal portion of the elongate tubular member, the anchor being configured to engage with the coronary sinus ostium, or both the coronary sinus ostium and a portion of the coronary sinus adjacent to the ostium, so as to provide stable transcatheter access into the coronary sinus. The anchor can be configured to permit blood flow through the ostium while in engagement with the ostium.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A steerable sheath comprising:
 an elongate tubular member comprising an inner lumen configured to receive a plurality of instruments; and   a partially circumferential balloon anchor disposed partially circumferentially on a distal portion of the elongate tubular member and the partially circumferential balloon anchor including a proximal balloon portion and a distal balloon portion;   wherein, when the partially circumferential balloon anchor is in an inflated state the distal balloon portion has a tapered longitudinal profile tapering toward a distal end of the partially circumferential balloon anchor, and the partially circumferential balloon anchor is configured to, while positioned to engage with a coronary sinus, permit blood flow through an ostium of the coronary sinus.   
     
     
         2 . The steerable sheath of  claim 1 , wherein the partially circumferential balloon anchor, in the inflated state, is configured to be positioned to engage with both the ostium and a portion of the coronary sinus adjacent to the ostium. 
     
     
         3 . The steerable sheath of  claim 1 , wherein the tapered longitudinal profile comprises a convex curvature. 
     
     
         4 . The steerable sheath of  claim 1 , wherein the partially circumferential balloon anchor is positioned around less than 50% of a circumference of the distal portion of the elongate tubular member. 
     
     
         5 . The steerable sheath of  claim 1 , wherein the partially circumferential balloon anchor comprises a textured exterior surface configured to engage with the ostium and a portion of the coronary sinus adjacent to the ostium. 
     
     
         6 . The steerable sheath of  claim 5 , wherein the textured exterior surface comprises a plurality of bumps. 
     
     
         7 . The steerable sheath of  claim 5 , wherein the textured exterior surface comprises a plurality of ridges. 
     
     
         8 . The steerable sheath of  claim 1 , wherein the proximal balloon portion extends laterally from the distal portion of the elongate tubular member, a deformable panel being coupled to the proximal balloon portion. 
     
     
         9 . The steerable sheath of  claim 1 , wherein the inner lumen is configured to receive a therapy device delivery catheter carrying a therapy device for deployment to a heart location. 
     
     
         10 . The steerable sheath of  claim 9 , wherein the therapy device comprises a shunt device for deployment onto a left atrial wall. 
     
     
         11 . A steerable sheath comprising:
 an elongate tubular member comprising an inner lumen configured to receive a plurality of instruments; and   a circumferential balloon anchor disposed circumferentially around a distal portion of the elongate tubular member, and a plurality of cords circumferentially distributed around the circumferential balloon anchor;   wherein, when the circumferential balloon anchor is in an inflated state the plurality of cords are configured to engage the circumferential balloon anchor to create corresponding circumferentially distributed indentations on the circumferential balloon anchor, and the circumferential balloon anchor is configured to, while positioned to engage with a coronary sinus, permit blood flow through an ostium of the coronary sinus along a path defined at least in part by the circumferentially distributed indentations.   
     
     
         12 . The steerable sheath of  claim 11 , wherein the circumferential balloon anchor, in the inflated state, is configured to be positioned to engage with the ostium. 
     
     
         13 . The steerable sheath of  claim 11 , wherein the circumferential balloon anchor comprises a proximal balloon portion and a distal balloon portion, and respective distal ends of the plurality of cords are coupled to corresponding locations on the distal balloon portion, the plurality of cords being movable relative to the elongate tubular member along a longitudinal axis of the elongate tubular member, and wherein moving the plurality of cords proximally relative to the elongate tubular member is configured to engage the circumferential balloon anchor in the inflated state with the plurality of cords to provide the corresponding circumferentially distributed indentations. 
     
     
         14 . The steerable sheath of  claim 13 , wherein the distal balloon portion comprises a tapered longitudinal profile tapering toward a distal end of the circumferential balloon anchor, the distal balloon portion being configured to engage with the ostium and a portion of the coronary sinus adjacent to the ostium. 
     
     
         15 . The steerable sheath of  claim 11 , wherein the plurality of cords comprises five cords. 
     
     
         16 . The steerable sheath of  claim 11 , wherein the circumferential balloon anchor comprises a textured exterior surface configured to engage with the ostium and a portion of the coronary sinus adjacent to the ostium. 
     
     
         17 . The steerable sheath of  claim 16 , wherein the textured exterior surface comprises a plurality of bumps. 
     
     
         18 . The steerable sheath of  claim 16 , wherein the textured exterior surface comprises a plurality of ridges. 
     
     
         19 . The steerable sheath of  claim 11 , wherein the inner lumen is configured to receive a therapy device delivery catheter carrying a therapy device for deployment to a heart location. 
     
     
         20 . The steerable sheath of  claim 19 , wherein the therapy device comprises a shunt device for deployment onto a left atrial wall. 
     
     
         21 . A method of accessing a heart location, the method comprising:
 providing a steerable sheath comprising an elongate tubular member, a circumferential balloon anchor circumferentially positioned around a distal portion of the elongate tubular member and a plurality of cords circumferentially distributed around the circumferential balloon anchor;   introducing the distal portion of the elongate tubular member through an inferior vena cava or a superior vena cava, and into a right atrium;   inserting a distal end of the elongate tubular member through an ostium of a coronary sinus into the coronary sinus from the right atrium, and positioning the distal end at a target location within the coronary sinus;   inflating the circumferential balloon anchor to engage an inflated circumferential balloon anchor with the plurality of cords to create corresponding circumferentially distributed indentations on the inflated circumferential balloon anchor; and   engaging the inflated circumferential balloon anchor with the coronary sinus while permitting blood flow through the ostium past the inflated circumferential balloon anchor along a path defined at least in part by the circumferentially distributed indentations.   
     
     
         22 . The method of  claim 21 , wherein engaging the coronary sinus comprises engaging the inflated circumferential balloon anchor with the ostium of the coronary sinus. 
     
     
         23 . The method of  claim 21 , further comprising moving the plurality of cords proximally along a longitudinal axis of the elongate tubular member, respective distal ends of the plurality of cords being coupled to corresponding locations on a distal balloon portion, wherein moving the plurality of cords compresses the inflated circumferential balloon anchor to provide the corresponding circumferentially distributed indentations on the inflated circumferential balloon anchor. 
     
     
         24 . The method of  claim 21 , further comprising inserting into an inner lumen of the elongate tubular member a delivery catheter carrying a therapy device, and advancing a distal end of the delivery catheter from the distal end of the elongate tubular member for positioning at the target location. 
     
     
         25 . The method of  claim 24 , wherein inserting into the inner lumen of the elongate tubular member a delivery catheter carrying a therapy device comprises inserting a shunt delivery catheter carrying an atrial shunt device. 
     
     
         26 . A steerable sheath comprising:
 an elongate tubular member comprising an inner lumen configured to receive a plurality of instruments; and   a deformable helical rib anchor disposed around a distal portion of the elongate tubular member, the deformable helical rib anchor being configured to engage with a coronary sinus, and to permit blood flow through an ostium of the coronary sinus along a path defined at least in part by the deformable helical rib anchor while the deformable helical rib is positioned to engage with the coronary sinus.   
     
     
         27 . The steerable sheath of  claim 26 , wherein the deformable helical rib anchor is configured to be positioned to engage with both the ostium of the coronary sinus and a portion of the coronary sinus adjacent to the ostium. 
     
     
         28 . The steerable sheath of  claim 26 , wherein a height at which the deformable helical rib anchor extends from the distal portion of the elongate tubular member increases with increased distance from a distal end of the elongate tubular member. 
     
     
         29 . The steerable sheath of  claim 26 , wherein a height at which the deformable helical rib anchor extends from the distal portion of the elongate tubular member is uniform along a dimension of the deformable helical rib anchor parallel with a longitudinal axis of the elongate tubular member. 
     
     
         30 . The steerable sheath of  claim 26 , wherein the inner lumen is configured to receive a therapy device delivery catheter carrying a therapy device for deployment to a heart location. 
     
     
         31 . The steerable sheath of  claim 30 , wherein the therapy device comprises a shunt device for deployment onto a left atrial wall. 
     
     
         32 . A steerable sheath comprising:
 an elongate tubular member comprising an inner lumen configured to receive a plurality of instruments; and   a first expandable coil anchor disposed around a distal portion of the elongate tubular member, the first expandable coil being configured to engage with a coronary sinus and to permit blood flow through an ostium of the coronary sinus while the first expandable coil anchor is in an expanded state and positioned to engage with the coronary sinus.   
     
     
         33 . The steerable sheath of  claim 32 , wherein the first expandable coil is configured to be positioned to engage with the ostium of the coronary sinus. 
     
     
         34 . The steerable sheath of  claim 32 , further comprising a second expandable coil anchor positioned distally adjacent to the first expandable coil anchor, the second expandable coil anchor comprising a diameter smaller than that of the first expandable coil anchor, the second expandable coil anchor being configured to engage with a portion of the coronary ostium adjacent to the ostium when in an expanded state, and the first expandable coil anchor and the second expandable coil anchor being configured to permit blood flow through the ostium while the first expandable coil anchor and the second expandable coil anchor are positioned to engage with the ostium and the portion of the coronary sinus adjacent to the ostium. 
     
     
         35 . The steerable sheath of  claim 32 , wherein the inner lumen is configured to receive a therapy device delivery catheter carrying a therapy device for deployment to a heart location. 
     
     
         36 . The steerable sheath of  claim 35 , wherein the therapy device comprises a shunt device for deployment onto a left atrial wall. 
     
     
         37 . A steerable sheath comprising:
 an elongate tubular member comprising an inner lumen configured to receive a plurality of instruments; and   a partially circumferential ring anchor disposed partially circumferentially on a distal portion of the elongate tubular member, the partially circumferential ring anchor being configured to permit blood flow through an ostium of a coronary sinus while the partially circumferential ring anchor is positioned to engage with the coronary sinus.   
     
     
         38 . The steerable sheath of  claim 37 , wherein the partially circumferential ring anchor is configured to be positioned to engage with the ostium. 
     
     
         39 . The steerable sheath of  claim 37 , wherein the partially circumferential ring anchor comprises a proximal ring portion and a distal ring portion, the distal ring portion comprising a tapered longitudinal profile tapering toward a distal end of the ring, the partially circumferential ring anchor being configured to engage with the ostium and a portion of the coronary sinus adjacent to the ostium. 
     
     
         40 . The steerable sheath of  claim 37 , wherein the partially circumferential ring is disposed around less than 50% of a circumference of the distal portion of the elongate tubular member. 
     
     
         41 . The steerable sheath of  claim 37 , wherein the inner lumen is configured to receive a therapy device delivery catheter carrying a therapy device for deployment to a heart location. 
     
     
         42 . The steerable sheath of  claim 41 , wherein the therapy device comprises a shunt device for deployment onto a left atrial wall. 
     
     
         43 . A method of accessing a heart location, the method comprising:
 providing a steerable sheath comprising an elongate tubular member and an anchor positioned on a distal portion of the elongate tubular member;   introducing the distal portion of the elongate tubular member through an inferior vena cava or a superior vena cava, and into a right atrium;   inserting a distal end of the elongate tubular member through an ostium of a coronary sinus into the coronary sinus from the right atrium, and positioning the distal end at a target location within the coronary sinus; and   engaging the anchor with the coronary sinus while permitting blood flow through the ostium past the anchor.   
     
     
         44 . The method of  claim 43 , wherein engaging the coronary sinus comprises engaging the ostium of the coronary sinus with the anchor. 
     
     
         45 . The method of  claim 43 , further comprising inserting into an inner lumen of the elongate tubular member a delivery catheter carrying a therapy device, and advancing a distal end of the delivery catheter from the distal end of the elongate tubular member for positioning at the target location. 
     
     
         46 . The method of  claim 45 , wherein inserting into the inner lumen of the elongate tubular member a delivery catheter carrying a therapy device comprises inserting a shunt delivery catheter carrying an atrial shunt device.

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